Testing the safety and effects of MT-501 in healthy adults

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Oral Doses of MT-501 in Healthy Volunteers

This study is testing a new drug called MT-501 in healthy adults to see how safe it is and how it works in the body.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 19 Years to 55 Years
• Sex: All
• Sponsor: Mirador Therapeutics, Inc. (industry)
• Locations: 1 site (San Diego, California)
• Trial ID: NCT06762457 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MT-501 through single and multiple ascending oral doses in healthy volunteers. Participants will receive doses over a period of up to 8 days, allowing researchers to gather crucial data on how the drug behaves in the body. The findings from this first-in-human study will guide the future development of MT-501.

Who should consider this trial

Good fit: Ideal candidates are healthy male and female adults aged 19 to 55 who meet specific health criteria.

Not a fit: Patients with significant organ system diseases or abnormal laboratory assessments will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to the development of a new treatment option based on the findings of MT-501's safety and effects.

How similar studies have performed: While this is a first-in-human study, similar studies have shown success in evaluating new drug candidates, indicating potential for positive outcomes.

Eligibility criteria

Inclusion Criteria:

1. Male or female (of non-childbearing potential only) between 19 and 55 years of age inclusive, at the time of signing informed consent.
2. Females must be of non-childbearing potential and must have undergone sterilization procedures, and have official documentation, at least 6 months prior to the first dose.
3. Male subjects must use highly effective forms of contraception during sexual intercourse with female partners of childbearing potential. A non-vasectomized, male subject must agree to use a condom with a chemical barrier method.
4. Continuous non-smoker who has not used tobacco or nicotine-containing products for at least 3 months prior to the first dose of drug.
5. Good general health.
6. Able to provide written informed consent and understand and comply with the requirements of the study.

Exclusion Criteria:

1. History or presence of any clinically significant organ system disease.
2. Abnormal laboratory assessments, physical exam of ECG outside the normal range that is judged by the Investigator to be clinically significant.
3. History of alcohol or drug abuse within the past 24 months.
4. Current use or history of regular tobacco, or nicotine-containing products within 3 months prior to screening.
5. Administration or use of any investigational drug or device within 30 days preceding the first does of study drug administration.

Where this trial is running

San Diego, California

• Mirador Clinical Department — San Diego, California, United States (RECRUITING)

Study contacts

• Study coordinator: Toll-Free Number

Conditions: Healthy Volunteers, MT-501, Phase 1